Background: The traditional approach to resolving ethics concerns may not address underlying organisational issues involved in the evolution of these concerns. This represents a missed opportunity to improve quality of care “upstream”. The purpose of this study was to understand better which organisational issues may contribute to ethics concerns. Methods: Directed content analysis was used to review ethics consultation notes from an academic children’s hospital from 1996 to 2006 (N = 71). The analysis utilised 18 categories of organisational issues derived (...) and modified from published quality improvement protocols. Results: Organisational issues were identified in 68 of the 71 (96%) ethics consult notes across a range of patient settings and reasons for consultation. Thirteen of the 18 categories of organisational issues were identified and there was a median of two organisational issues per consult note. The most frequently identified organisational issues were informal organisational culture (eg, collective practices and approaches to situations with ethical dimensions that are not guided by policy), policies and procedures (eg, staff knows policy and/or procedural guidelines for an ethical concern but do not follow it) and communication (eg, communication about critical information, orders, or hand-offs repeatedly does not occur among services). Conclusions: Organisational issues contribute to ethical concerns that result in clinical ethics consults. Identifying and addressing organisational issues such as informal culture and communication may help decrease the recurrence of future similar ethics concerns. (shrink)

Health behaviors such as tobacco use contribute significantly to poor health. It is widely recognized that efforts to prevent poor health outcomes should begin in early childhood. Biomedical enhancements, such as a nicotine vaccine, are now emerging and have potential to be used for primary prevention of common diseases. In anticipation of such enhancements, it is important that we begin to consider the ethical and policy appropriateness of their use with children. The main ethical concerns raised by enhancing children relate (...) to their impact on children’s well-being and autonomy. These concerns are significant, however they do not appear to apply in the case of the nicotine vaccine; indeed the vaccine could even further these goals for children. Nevertheless, concerns about broadly applying this enhancement may be more challenging. The vaccine may be less cost-effective than alternative public efforts to prevent tobacco use, utilizing it could distract from addressing the foundational causes of smoking and it might not be publically acceptable. Empirical research about these concerns is needed to ascertain their likelihood and impact as well as how they could be minimized. This research could help determine whether behavior-related enhancements hold promise for improving children’s health. (shrink)

The target articles in this issue advance our understanding of bioethical considerations in pragmatic trials (Garland, Morain, and Sugarman 2023; Morain and Largent 2023). Both articles appreciate...

The ethical principle of ‘respect for persons’ in clinical research has traditionally focused on protecting individuals’ autonomy rights, but respect for participants also includes broader, although less well understood, ethical obligations to regard individuals’ rights, needs, interests and feelings. However, there is little empirical evidence about how to effectively convey respect to potential and current participants. To fill this gap, we conducted exploratory, qualitative interviews with participants in a clinical genomics implementation study. We interviewed 40 participants in English or Spanish (...) about their experiences with respect in the study and perceptions of how researchers in a hypothetical observational study could convey respect or a lack thereof. Most interviewees were female, identified as Hispanic/Latino or non-Hispanic white, reported annual household income under US$60 000 and did not have a Bachelor’s degree ; 30% had limited health literacy. We identified four key domains for demonstrating respect: personal study team interactions, with an emphasis on empathy, appreciation and non-judgment; study communication processes, including following up and sharing results with participants; inclusion, particularly ensuring materials are understandable and procedures are accessible; and consent and authorisation, including providing a neutral informed consent and keeping promises regarding privacy protections. While the experience of respect is inherently subjective, these findings highlight four key domains that may meaningfully demonstrate respect to potential and current research participants. Further empirical and normative work is needed to substantiate these domains and evaluate how best to incorporate them into the practice of research. (shrink)

Genomic research results and incidental findings with health implications for a research participant are of potential interest not only to the participant, but also to the participant's family. Yet investigators lack guidance on return of results to relatives, including after the participant's death. In this paper, a national working group offers consensus analysis and recommendations, including an ethical framework to guide investigators in managing this challenging issue, before and after the participant's death.

Background: Clinical genomic implementation studies pose challenges for informed consent. Consent forms often include complex language and concepts, which can be a barrier to diverse enrollment, and these studies often blur traditional research-clinical boundaries. There is a move toward self-directed, web-based research enrollment, but more evidence is needed about how these enrollment approaches work in practice. In this study, we developed and evaluated a literacy-focused, web-based consent approach to support enrollment of diverse participants in an ongoing clinical genomic implementation study. (...) Methods: As part of the Cancer Health Assessments Reaching Many (CHARM) study, we developed a web-based consent approach that featured plain language, multimedia, and separate descriptions of clinical care and research activities. CHARM offered clinical exome sequencing to individuals at high risk of hereditary cancer. We interviewed CHARM participants about their reactions to the consent approach. We audio recorded, transcribed, and coded interviews using a deductively and inductively derived codebook. We reviewed coded excerpts as a team to identify overarching themes. Results: We conducted 32 interviews, including 12 (38%) in Spanish. Most (69%) enrolled without assistance from study staff, usually on a mobile phone. Those who completed enrollment in one day spent an average of 12 minutes on the consent portion. Interviewees found the information simple to read but comprehensive, were neutral to positive about the multimedia support, and identified increased access to testing in the study as the key difference from clinical care. Conclusions: This study showed that interviewees found our literacy-focused, web-based consent approach acceptable; did not distinguish the consent materials from other online study processes; and valued getting access to testing in the study. Overall, conducting empirical bioethics research in an ongoing clinical trial was useful to demonstrate the acceptability of our novel consent approach but posed practical challenges. (shrink)

Returning genomic research results to family members raises complex questions. Genomic research on life-limiting conditions such as cancer, and research involving storage and reanalysis of data and specimens long into the future, makes these questions pressing. This author group, funded by an NIH grant, published consensus recommendations presenting a framework. This follow-up paper offers concrete guidance and tools for implementation. The group collected and analyzed relevant documents and guidance, including tools from the Clinical Sequencing Exploratory Research Consortium. The authors then (...) negotiated a consensus toolkit of processes and documents. That toolkit offers sample consent and notification documents plus decision flow-charts to address return of results to family of living and deceased participants, in adult and pediatric research. Core concerns are eliciting participant preferences on sharing results with family and on choice of a representative to make decisions about sharing after participant death. (shrink)

The case presented here is tragic, not just in the sense of being a sad story, but in the dramatic meaning of tragedy. It presents us with a situation where there is no clear path, where moral ambiguity exists, and where no possible solution could unequivocally be declared the right or good one. Ethical deliberation can help here, but only as a way of clarifying the issues and offering reasonable solutions. It cannot show us the one right way.Baby G has (...) profound medical conditions, including respiratory failure, a chest wall deformity that will require surgery, and profound neurodevelopmental disability. Even a best case scenario portends a shortened lifespan and.. (shrink)

In International Law and World Order, B. S. Chimni articulates an integrated Marxist approach to international law combining the insights of Marxism, socialist feminism and postcolonial theory. The book uses IMAIL to systematically and critically examine the most influential contemporary theories of international law including new, feminist, realist and policy-oriented approaches. In doing so, it discusses a range of themes relating to the history, structure and process of international law. The book also considers crucial world order issues and problems that (...) the international legal process has to contend with, including the welfare of weak groups and nations, the ecological crisis and the role of human rights. This extensively revised second edition provides an invaluable, in-depth and updated review of the key literature and scholarship within this field of study. It will be of particular interest to students and scholars of international law, international relations, international politics and global studies. (shrink)

Objectives: To compare attitudes of medical and law students toward informing a cancer patient about diagnosis and prognosis and to examine whether differences are related to different convictions about benefit or harm of information.Setting and design: Anonymous questionnaires were distributed to convenience samples of students at the University of Geneva containing four vignettes describing a cancer patient who wishes, or alternatively, who does not wish to be told the truth.Participants: One hundred and twenty seven medical students and 168 law students.Main (...) outcome measures: Five point Likert scale of responses to the vignettes ranging from “certainly inform” to “certainly not inform” the patient.Results: All medical students and 96% of law students favoured information about the diagnosis of cancer if the patient requests it. Seventy four per cent of medical students and 82% of law students favoured informing a cancer patient about his or her prognosis . Thirty five per cent of law students and 11.7% of medical students favoured telling about the diagnosis and 25.6% of law students and 7% of medical students favoured telling about the prognosis even if the patient had clearly expressed his wish not to be informed. Law students indicated significantly more often than medical students reasons to do with the patient’s good, legal obligations, and the physician’s obligation to tell the truth, and significantly less often than medical students that their attitude had been determined predominantly by respect for the autonomous choice of the patient.Conclusion: Differences in attitudes according to the type of case and the type of studies were related to convictions about the benefit or harm to the patient caused by being given information. The self reported reasons of future physicians and future lawyers are helpful when considering means to achieve a better acceptance of patients’ right to know and not to know. (shrink)

John Burdon Sanderson Haldane was a giant among men. He made major contributions to genetics, population biology, and evolutionary theory. He was at once comfortable in mathematics, chemistry, microbiology and animal physiology. But it was his belief in education that led to his preparing his popular essays for publication. In his own words: "Many scientific workers believe that they should confine their publications to learned journals. I think that the public has a right to know what is going on inside (...) the laboratories, for some of which it pays." So begins Haldane's collection of essays, perhaps the most public intellectual communicating science before the writings of Stephen Jay Gould. The first part of the volume emphasizes the important developments in biology and natural science in the first quarter of the century. As such, it provides a benchmark for studies of the next three quarters of the century. In an unusual introduction, Price takes the readers through their paces, discussing the situation then and now in vitamins, oxygen want, disease controls, and the rewards of science as such. This is followed by Haldane's views on society, art, religion and economy as seen through the eyes of a politically alert major scientist. The editor provides readers unfamiliar with Haldane with a carefully rendered chronology of a life that began in 1892 and that spanned much of the present century. Despite ideas on race, class and politics that have seen better times, Haldane was truly exceptional in translating the science of his time into ideas that "everyman" could readily grasp. His predictions on what science would achieve were on target far more often than not. But even his failed predictions are perhaps the most interesting of all. They throw into sharp relief the truly novel and revolutionary developments in science over the past 75 years. J.B.S. Haldane held many positions and received many honors during his lifetime. But for most of the period covered in this volume, he was the William Dunn Reader in Biochemistry at Cambridge University. He simultaneously served as Fellow of New College, in Oxford University's Horticultural Institute. Carl A. Price served until 1999 as professor IIof plant molecular biology in the Waksman Institute of Microbiology at Rutgers, the State University of New Jersey. He also served as the editor of Plant Molecular Biology Reporter from 1983 until 1997. This is the first volume in a new series on the history and theory of science. (shrink)

In his account of probable reasoning, Poincare used the concept, or at least the language, of conventions. In particular, he claimed that the prior probabilities essential for inverse probable reasoning are determined conventionally. This paper investigates, in the light of Poincare's well known claim about the conventionality of metric geometry, what this could mean, and how it is related to other views about the determination of prior probabilities. Particular attention is paid to the similarities and differences between Poincare's conventionalism as (...) it applies to probabilities and de Finetti's subjectivism. The aim of the paper is to suggest that in accounts of the development of ideas about probable reasoning, particularly those customarily described as Bayesian, Poincare's discussion deserves more attention than it has so far received. (shrink)

Simultaneous discovery in science has been a subject of close historical investigations, not only for assessing claims of priority, which occasionally generate controversy rather than consensus, but also for understanding the cultural and intellectual context of the time. Thomas S. Kuhn is a pioneer in the contextual study of simultaneous discovery, and his paper on the formulation of the first law of thermodynamics has already become a classic.